Biopharmaceuticals are manufactured by genetically modified microbes*4 or mammalian cells. Antibodies are an important class of biopharmaceutical, they are well established as safe and efficacious treatments and are manufactured in high volumes. The structural complexity of these entities means that they are usually produced in mammalian cells.
In the manufacture of antibodies, the following technologies are key to obtaining good cell lines, 1. nature of the host cells used, 2. genetic engineering technology, 3. screening technology and 4. media and feed for cell culture*5.

“Apollo™” is a unique set of technologies established by the expertise, experience and know-how which FDBU and FDBK have been accumulating through their long history in the biopharmaceutical CMO industry,
and comprises four key components, 1. a new CHO DG44-derived host cell line*6 with proven track record, 2. a novel expression vector*7, 3. high throughput screening technology and 4. animal component-free media
and feed which maximize cell culture performance.

“Apollo™” offers to clients two major benefits:

30% shorter development period:
A manufacturing-ready cell line is available in 25 weeks, which is about thirty percent shorter than previously.

Five-fold increase in protein productivity:
Titers can be increased up to 5 times as high as previously. The developed cell line is stable and maintains high productivity on scale-up.

“Apollo™” realizes top-tier performances in the industry and brings about benefit for various stages from early development to clinical and commercial supply. It will contribute to swift launch of innovative, novel biopharmaceuticals through helping clients shorten their development timeline.

FDBU and FDBK are biopharmaceutical CMOs which Fujifilm acquired from Merck&Co.,Inc. in 2011. They operate efficient manufacture of high-quality biopharmaceuticals utilizing the technologies and resources of total Fujifilm group. Fujifilm intends to expand its CMO business, making best of existing, well trusted platforms for microbial culture (pAVEwayTM) and insect-cell culture, along with the “Apollo™” platform announced today and by increasing manufacturing capacity to meet clients need.

* Biopharmaceutical:
Pharmaceutical products manufactured through biological process, which usually functions differently from small molecule drugs. It includes various products such as vaccine, insulin, growth hormone, antibodies, etc.

** Contract Manufacturing Organization:
An organization which provides contract services to the pharmaceutical industry. Its services range from cell line development to manufacturing of clinical materials, and commercial production, etc.

*** Cell line:
A group of clonal cells capable of growing permanently while sustaining certain characteristics. For example normal human cell is limited in number of times it can divide, while some types of cells have the ability to continue growing unlimitedly, either by nature or as a result of artificial modification. Chinese hamster ovary (CHO) cell is a type widely used in manufacturing of antibodies, genetically modified to grow stably for a long period of time, producing proteins.

*4 Microbe:
A group of clonal microbes capable of growing permanently while sustaining certain characteristics. Genetic modification enables microbes to grow stably for a long period of time, producing proteins.

*5 Media and feed for cell culture:
A chemical entity used in bioprocess which is specially designed to support the growth of cells.

*6 CHO DG44-derived host cell line:
Chinese hamster ovary (CHO) cell is the most commonly-used type of cell in mammalian cell culture. There are multiple subspecies of CHO cells, one of which with proven track record is DG44.

*7 Expression vector: A nucleic acid molecule designed to introduce foreign gene into a host cell.

How biopharmaceuticals are manufactured

Multiple candidates for microbe/cell line are established by utilizing vectors in order to modify the gene of microbe/mammalian cell suitable for biopharmaceutical manufacturing. These candidates go through the process of screening and the best microbe/cell line is chosen based on several aspects of performance such as protein production, cell growth, and genetic stability of the cells.

This chosen microbe/cell line is fed and grown in a bioreactor. The clones eventually produce proteins, which are then purified and formulated to be a biopharmaceutical product.